Early Phase 1
N=26
The Effectiveness of Osteopathic Manipulative Medicine in the Management of Headaches Associated With Post Concussion Syndrome
Headache · Post-Concussion Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT04732338 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
May 2021
Primary outcome: Primary: Immediate Change in Headache Scores With a Visual Analog Scale (VAS) — 5.6; NA; 3.5; NA units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Osteopathic Manipulative Therapy (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hackensack Meridian Health
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Immediate Change in Headache Scores With a Visual Analog Scale (VAS) |
5.6; NA; 3.5; NA; 2; NA | — |
| PRIMARY Change in the 6-item Headache Impact Test (HIT-6) Between Baseline and Follow-up Visit. |
63.0; 62.0; 60.0; 60.5; 3.5; 2.0 | — |
Summary
Pilot study looking at the Osteopathic Manipulative Treatment (OMT) for various headache types in patients with post-concussion syndrome (PCS). Twenty-six subjects with symptoms lasting >3 months were enrolled and were randomly assigned to a treatment group (n = 13) and a control group (n = 13).
Eligibility Criteria
Inclusion Criteria
- diagnosis of mild traumatic brain injury (MTBI),
- age 18 years or older
- injury occurring >3 months prior, and
- headache as a primary symptomatic concern.
Exclusion Criteria
- history of moderate to severe traumatic brain injury (TBI),
- documented intracranial injury,
- chronic headache or migraine headache before the injury,
- treatment with a headache specialist at the time of injury, or receipt of IV infusion for medication for headache at the time of treatment.
Data sourced from ClinicalTrials.gov (NCT04732338). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.